Abbott Alinity m System Recall: Incorrect Optical Calibration Risk
Abbott recalls Alinity m System (REF 08N53-002) for incorrect optical calibration that may affect diagnostic accuracy. No immediate action needed but check for serial number 00654.
Lower-risk recall
Incorrect optical calibration
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What happened, in plain English
Abbott is recalling the Alinity m System (REF 08N:002) due to incorrect optical calibration, which could lead to inaccurate diagnostic results. This affects laboratory equipment used for in vitro diagnostics. Read more at govinfonow.com/recall/60356-abbott-alinity-m-system-recall-incorrect-optical-calibration-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/60356-abbott-alinity-m-system-recall-incorrect-optical-calibration-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1518-2022
Cite this page
“Abbott Alinity m System Recall: Incorrect Optical Calibration Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60356-abbott-alinity-m-system-recall-incorrect-optical-calibration-risk. Based on FDA recall #Z-1518-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1518-2022%22&limit=1).
Why it’s dangerous
Incorrect optical calibration can cause the system to produce inaccurate diagnostic results. This may lead to incorrect medical decisions if the equipment is used for critical testing.
Who’s affected
Laboratories using the Alinity m System for in vitro diagnostics are affected. Users most at risk are those relying on accurate test results for medical diagnosis.
How to tell if you have this one
Check for the model reference 08N53-002 and serial number 00654 on the device. The product is used for in vitro diagnostic purposes.
- Brand
Abbott Molecular- Category
Medical device
What to do — step by step
Check Device Details
Look for the model reference 08N53-002 and serial number 00654 on the Alinity m System.
How this recall unfolded
Recall timeline
FDA published this recall 36 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1518-2022 (July 19, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1518-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.